Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial

Non-small Cell Lung Cancer Clinical Trial

— FLAIR  

Official title:

Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02002052
• Other study ID #: UWO-FLAIR
• Status: Terminated
• Phase: Phase 2
• Start date: May 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%, and is associated with a decline in pulmonary quality of life.

Standard radiation planning aims to optimize dose to the anatomic lung volume, without consideration of the differences in regional lung function. Functional lung avoidance radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead depositing dose in areas of lung that are not well-ventilated. Functional lung regions are determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans. Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs. functional lung avoidance radiotherapy (with concurrent chemotherapy).

Description:

All consenting patients will undergo hyperpolarized noble gas MRI using 3-He for definition of functional lung volumes. Two radiotherapy treatment plans will be generated prior to randomization: one standard plan using anatomical lung avoidance, and one functional lung avoidance plan. After approval of both plans, patients will be randomized, and both patients and physicians will be blinded to treatment allocation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Willing to provide informed consent

• ECOG performance status 0-2

• Histologically confirmed non-small cell lung carcinoma

• Locally advanced Stage IIIA or IIIB lung carcinoma according to AJCC 7th edition

• History of at least 10-pack-years of smoking

• Not undergoing surgical resection

• Assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy

Exclusion Criteria:

• Contraindications to MRI

• Serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy

• Prior history of lung cancer within 5 years

• Prior thoracic radiation at any time

• Metastatic disease. Patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent.

• Inability to attend full course of radiotherapy or follow-up visits

• Pregnant or lactating women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Concurrent platinum-based chemotherapy
Platinum-based concurrent chemotherapy in both arms

Radiation:
• Standard Radiotherapy, 60 Gy in 30 fractions.

• Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary quality of life 3-months post-treatment.	Measured using the Functional-Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)	3-months post-treatment
Secondary	Quality of life at other time points	Measured using the FACT-LCS, FACT-TOI, and FACT-L	up to 1 year
Secondary	Toxicity	CTC-AE version 4	up to 1 yr
Secondary	Overall Survival	Defined as time from randomization to death from any cause	5-years
Secondary	Progression Free Survival	Time from randomization to disease progression at any site or death	Up to 5 years
Secondary	Quality-adjusted survival	Based on utilities from EQ-5D	Up to 5 years